Socializing a Science-Based Digital Therapeutic for Substance Use Disorders

NCT ID: NCT05648786

Last Updated: 2025-01-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 189 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-09
• Study Completion Date: 2024-12-31

Brief Summary

The purpose of this study is to evaluate the effectiveness of an intervention delivered on a smartphone. This study examines whether this intervention might improve treatment outcomes for people with substance use disorders. The intervention, called Laddr®, is a smartphone application ("app") that provides information and skills that can help people stop using substances. The social version of Laddr® being tested in this study has new features that allow people in treatment for substance use disorders to include a support person in their treatment journey, including a friend, family member, or other acquaintance. This research study will compare the effectiveness of Laddr® in combination with standard outpatient substance use treatment to standard treatment only for substance use disorders.

Detailed Description

Digital therapeutics, or software used to prevent, treat, or manage a medical disorder or disease, are redefining the future of healthcare by providing on-demand access to state-of-the-science care. Digital therapeutics have been developed to treat a wide range of disorders, including substance use disorders (SUD). Developed by the study Principal Investigator (PI) and Co-Investigator (Co-I), Laddr® is a unique mobile platform integrating science-based therapeutic processes to address a wide range of behavioral problems, including SUD.

The current project expands Laddr® to allow users to engage a support network of their choosing in their journey of behavioral change. Individuals can share data from Laddr about their successes and challenges, and their support network can offer anytime/anywhere social support. Social support will be embedded within a strongly science-based digital therapeutic process - thus providing support persons with a clear framework in which to offer support. Research has shown that engaging a support network of non-substance users (e.g., family members, friends) in one's SUD treatment can greatly enhance treatment outcomes - and is aligned with the "community reinforcement" tenet of the CRA treatment model. Interventions that leverage social support networks can help keep individuals engaged in treatment, reinforce their successes, and help them troubleshoot challenges.

This pragmatic, randomized controlled trial aims to evaluate the effectiveness of the social version of Laddr® in improving SUD treatment outcomes. Adults entering outpatient SUD treatment at the Farnum Center in Manchester, New Hampshire (NH) will be offered the opportunity to be randomized to 12 weeks of standard treatment (treatment as usual [TAU] arm), or standard treatment plus the social version of Laddr® (Laddr® arm). The primary study outcome is retention in SUD treatment (time to treatment dropout), and the investigators hypothesize that participants receiving Laddr® will be retained in treatment for a longer duration. Secondary outcomes include participant substance use (self-report and urine toxicology), stages of change, coping skills, recovery capital, and treatment acceptability.

Conditions

Substance Use Disorders; Substance-Related Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard outpatient treatment plus Laddr®

Laddr® is a smartphone application integrating science-based, therapeutic processes to address a wide range of behavioral problems in the context of a single mobile platform. Laddr includes tools for activating behavior change, solving problems and overcoming obstacles to effective behavior change; teaching skills and providing guidance on the execution of behavior change; and maintaining the end user's motivation to change. It enables longitudinal assessment of individuals' behavior and health status in naturalistic contexts, offers science-based self-regulation behavior change tools of relevance to an array of populations, and enables ongoing monitoring of health behavior. This study evaluates the effectiveness of new features to Laddr®. These new features are designed to be used with a support person, which could include a friend, family member, or acquaintance.

In addition to Laddr®, participants will receive standard outpatient substance use disorder treatment.

Group Type: EXPERIMENTAL

Laddr® plus Behavioral- Group and individual counseling

Intervention Type: BEHAVIORAL

Smartphone application utilizing the Community Reinforcement Approach (CRA) to facilitate social support in substance use treatment.

Outpatient treatment will include a range of services, including group counseling, individual counseling, medication treatment, and other recovery support services.

Standard outpatient treatment

The active control condition consists of standard outpatient treatment for substance use disorders. Outpatient treatment will include a range of services, including group counseling, individual counseling, medication treatment, and other recovery support services.

Group Type: ACTIVE_COMPARATOR

Behavioral- Group and individual counseling

Intervention Type: BEHAVIORAL

The active control condition consists of standard outpatient treatment for substance use disorders. Outpatient treatment will include a range of services, including group counseling, individual counseling, medication treatment, and other recovery support services.

Interventions

Laddr® plus Behavioral- Group and individual counseling

Smartphone application utilizing the Community Reinforcement Approach (CRA) to facilitate social support in substance use treatment.

Outpatient treatment will include a range of services, including group counseling, individual counseling, medication treatment, and other recovery support services.

Intervention Type: BEHAVIORAL

Behavioral- Group and individual counseling

The active control condition consists of standard outpatient treatment for substance use disorders. Outpatient treatment will include a range of services, including group counseling, individual counseling, medication treatment, and other recovery support services.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• In first 30 days of new outpatient treatment episode at the Farnum Center
• 18 years of age or older
• Ability to provide informed consent
• Has access to a functioning smartphone
• Able to identify a support person who can participate in the study with them
• Available to participate for the full duration of the study.

Exclusion Criteria

• Inability to understand or read English.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Square2 Systems, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Grabinski

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Farnum Center

Manchester, New Hampshire, United States

Countries

United States

Other Identifiers

2R44DA047150

Identifier Type: NIH

Identifier Source: secondary_id

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2R44DA047150

Identifier Type: NIH

Identifier Source: org_study_id

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